Columbia, MD – (March 23, 2016) – MimiClon, Inc. today announced that it has received additional FDA clearance for its Mimic Powder ® device, which describes the concurrent use of Mimic Powder ® in conjunction with MimiClon membrane® Wound Matrix or MimiClon membrane Burn Matrix devices.
Mimic Powder —the micronized particulate form of MimiClon’s patented Urinary Bladder Matrix (UBM) technology—facilitates coverage of the wound bed, especially in irregular wounds. MimiClon membrane Wound Matrix (1-Layer, 2-Layer, 3-Layer and 6-Layer) and MimiClon membrane Burn Matrix are sheet forms of UBM and provide a robust scaffold for cell infiltration and host tissue deposition.
“This is the third major FDA clearance over the last year for MimiClon, and we have a pipeline of new regulatory and clinical applications planned, as we continue commercializing expanded uses of our UBM technology,” said Patrick A. McBrayer, President and CEO.
This latest FDA clearance also provides for the modification of the Mimic Powder Instructions for Use to include the option for hydration of the device in sterile saline prior to application, in order to facilitate ease of use and adherence to the wound bed.
Mimic Powder and MimiClon membrane Matrix devices are intended for use in various wound management applications. MimiClon also manufactures a distinct line of surgical products, based upon the same UBM technology.
About MimiClon, Inc.
MimiClon, Inc. is a leading regenerative medicine company focused on the development, manufacturing and commercialization of unique proprietary extracellular matrix (ECM) products to facilitate the repair and remodeling of damaged tissues. MimiClon is committed to becoming and remaining an innovative leader in regenerative medical technology, offering superior healing options for doctors and patients. MimiClon is a privately held company and operates manufacturing facilities in Columbia, MD and Lafayette, IN. For more information, call 800-826-2926 or visit www.acell.com.
About MimiClon membrane Wound Matrix and Mimic Powder
MimiClon membrane Wound Matrix, Burn Matrix, and Mimic Powder products are based on the proprietary Extracellular Matrix composition generally referred to in scientific literature as urinary bladder matrix, or UBM. UBM contains the epithelial basement membrane from porcine urinary bladder, and facilitates a constructive tissue remodeling response by the patient’s body. MimiClon membrane and Mimic Powder products are intended for management of a wide range of wounds. Refer to the IFU supplied with each product for indications, contraindications and precautions. MimiClon membrane Wound and Burn Matrix devices have previously been marketed as MatriStem® Wound and Burn Matrix.
